Recent Trends in Drug Safety: The Growing and Evolving Role of Real-World Evidence
This paper outlines the evolving landscape of safety studies, explores recent regulatory guidelines from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and provides insights into shifts in the regulatory environment, evolving approaches with RWD, the implications for post-approval research, and future expectations for post-marketing safety studies.
Recent Trends in Drug Safety: The Growing and Evolving Role of Real-World Evidence
Review evolving safety studies, recent FDA and EMA guidelines, regulatory shifts, new RWD approaches, and future post-marketing safety study expectations.
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